510(k) · Cleared
Recalled · Class II · 2019EliA RF IgM Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · DHR System, Test, Rheumatoid Factor
Cleared on Dec 18, 2018 as substantially equivalent to K102673 (Phadia US, Inc., 2011) after an 81-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.
- Decided
- Dec 18, 2018
- Review
- 81 days
- Class
- Class II
- Product code
- DHR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971614 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971614 | Quanta Lite RF Igm | Inova Diagnostics, Inc. | 1997 | — |
| −1 | K102673 | Rheumatoid Factor Immunological Test System | Phadia US, Inc. | 2011 | 1 |
| 0 (this device) | K182747 | EliA RF IgM Immunoassay | Phadia AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102673 | Rheumatoid Factor Immunological Test SystemSummary page 6…2500/5000 K182747.510kSummary.FINAL.doc A.6-3 I. Device Description: The method-specific reagents are identical with K102673, but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells: - E… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2019 | Class II | Z-1907-2019 | Nonconforming Material/Component | Potential for reporting low assay results |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All DHR devicesDHR System, Test, Rheumatoid Factor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DHR
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · DHR
Too few DHR 510(k)s in any year since 2007 to give a median.
Recalls per year · DHR
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHR
2in 2025
MAUDE reports naming product code DHR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 19 |
| 2011 | 1 | — | 3 | 400 |
| 2012 | 0 | — | 2 | 91 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 2 | 1 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 2500/5000.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182747 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182747: EliA RF IgM Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182747
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026